The following data is part of a premarket notification filed by Syva Co. with the FDA for Syva Microtrak(r) Ii Chlamydia Eia Block Reagent.
| Device ID | K926090 |
| 510k Number | K926090 |
| Device Name: | SYVA MICROTRAK(R) II CHLAMYDIA EIA BLOCK REAGENT |
| Classification | Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) |
| Applicant | SYVA CO. P.O. BOX 49013 San Jose, CA 95161 -9013 |
| Contact | Paul L Rogers |
| Correspondent | Paul L Rogers SYVA CO. P.O. BOX 49013 San Jose, CA 95161 -9013 |
| Product Code | LJC |
| CFR Regulation Number | 866.3120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-02 |
| Decision Date | 1993-09-30 |